ORCA PAIN RELIEVER PUTTY WITH MENTHOL- menthol paste 
ORCA Products, LLC

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ORCA Pain Reliever Putty with Menthol

Drug Facts

Active ingredient

Menthol 1.6%

Purpose

oral pain reliever

Use

Warnings

Do not use

  • this product for more than 7 days unless directed by a dentist or doctor.

When using this product

  • do not exceed recommended dosage.

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days 
  • irritation, pain, or redness persists or worsens 
  • swelling, rash, or fever develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Cinnamomum Zeylanicum Bark Oil, Elettaria Cardamomum Seed Oil, Eugenol, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Guaiacol, Maltodextrin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Xanthan Gum, Xylitol

Questions?

1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)

Package Labeling: 82939-001-01

putty labelputty lid label

ORCA PAIN RELIEVER PUTTY WITH MENTHOL 
menthol paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82939-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8.4 mg  in 0.525 g
Inactive Ingredients
Ingredient NameStrength
CARDAMOM OIL (UNII: JM0KJ091HZ)  
CHAMOMILE (UNII: FGL3685T2X)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
CLOVE OIL (UNII: 578389D6D0)  
GLYCERIN (UNII: PDC6A3C0OX)  
GUAIACOL (UNII: 6JKA7MAH9C)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
TEA TREE OIL (UNII: VIF565UC2G)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82939-001-011 in 1 PACKAGE09/15/202212/20/2024
14.2 g in 1 JAR; Type 0: Not a Combination Product
2NDC:82939-001-021 in 1 BLISTER PACK09/15/2022
27 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02209/15/2022
Labeler - ORCA Products, LLC (117716283)
Registrant - ORCA Products, LLC (117716283)

Revised: 11/2023
Document Id: 09ce4763-a8e6-7cff-e063-6294a90a851c
Set id: 188cb01a-3d0f-43d9-983e-6475c0c5b06e
Version: 3
Effective Time: 20231110
 
ORCA Products, LLC